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Randomised clinical trial

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https://www.readbyqxmd.com/read/28088592/a-systematic-review-found-that-deviations-from-intention-to-treat-are-common-in-randomized-trials-and-systematic-reviews
#1
Iosief Abraha, Francesco Cozzolino, Massimiliano Orso, Mauro Marchesi, Antonella Germani, Guido Lombardo, Paolo Eusebi, Rita De Florio, Maria Laura Luchetta, Alfonso Iorio, Alessandro Montedori
OBJECTIVES: To describe the characteristics, and estimate the incidence, of trials included in systematic reviews deviating from the intention-to-treat (ITT) principle. STUDY DESIGN AND SETTING: A 5% random sample of reviews (Medline 2006 to 2010). Trials from reviews were classified based on the intention-to-treat: 1) ITT trials (trials reporting standard ITT analyses); 2) mITT trials (modified ITT; trials deviating from standard ITT); or 3) no ITT trials. RESULTS: Of 222 reviews, 81 (36%) included at least one mITT trial...
January 11, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28088203/a-3-arm-randomised-controlled-trial-of-communicating-healthy-beginnings-advice-by-telephone-chat-to-mothers-with-infants-to-prevent-childhood-obesity
#2
Li Ming Wen, Chris Rissel, Louise A Baur, Alison J Hayes, Huilan Xu, Anna Whelan, Myna Hua, Miranda Shaw, Philayrath Phongsavan
BACKGROUND: With an increasing prevalence of obesity in young children globally, there is an urgent need for the development of effective early interventions. A previous Healthy Beginnings Trial using a nurse-led home visiting program has demonstrated that providing mothers with evidence-based advice can improve maternal practice regarding obesity prevention, and can reduce Body Mass Index (BMI) in the first few years of life. However, the costs for scale-up of home visiting limit its population reach...
January 14, 2017: BMC Public Health
https://www.readbyqxmd.com/read/28086943/a-lifestyle-intervention-among-elderly-men-on-active-surveillance-for-non-aggressive-prostate-cancer-a-randomised-feasibility-study-with-whole-grain-rye-and-exercise
#3
Anne Kirstine Eriksen, Rikke Dalgaard Hansen, Michael Borre, Ryan Godsk Larsen, Jeppe Munthe Jensen, Kristian Overgaard, Mette Borre, Cecilie Kyrø, Rikard Landberg, Anja Olsen, Anne Tjønneland
BACKGROUND: The prognosis for men with non-aggressive prostate cancer is good, and several studies have investigated the impact of lifestyle changes including physical activity and diet on the prognosis. Despite positive results in animal studies and a few human interventions with whole-grain rye on markers of prostate cancer progression, the feasibility of trials investigating such dietary changes in combination with physical activity remains largely unstudied. The primary aim was to investigate the feasibility of an intervention with high whole-grain rye intake and vigorous physical activity for 6 months in men diagnosed with prostate cancer...
January 13, 2017: Trials
https://www.readbyqxmd.com/read/28086890/feasibility-and-preliminary-efficacy-of-the-heyman-healthy-lifestyle-program-for-young-men-a-pilot-randomised-controlled-trial
#4
Lee M Ashton, Philip J Morgan, Melinda J Hutchesson, Megan E Rollo, Clare E Collins
BACKGROUND: In young men, unhealthy lifestyle behaviours can be detrimental to their physical and/or mental health and set them on a negative health trajectory into adulthood. Despite this, there is a lack of evidence to guide development of effective health behaviour change interventions for young men. This study assessed the feasibility and preliminary efficacy of the 'HEYMAN' (Harnessing Ehealth to enhance Young men's Mental health, Activity and Nutrition) healthy lifestyle program for young men...
January 13, 2017: Nutrition Journal
https://www.readbyqxmd.com/read/28086851/efficacy-of-intermittent-theta-burst-stimulation-itbs-and-10-hz-high-frequency-repetitive-transcranial-magnetic-stimulation-rtms-in-treatment-resistant-unipolar-depression-study-protocol-for-a-randomised-controlled-trial
#5
Samuel Bulteau, Veronique Sébille, Guillemette Fayet, Veronique Thomas-Ollivier, Thibault Deschamps, Annabelle Bonnin-Rivalland, Edouard Laforgue, Anne Pichot, Pierre Valrivière, Elisabeth Auffray-Calvier, June Fortin, Yann Péréon, Jean-Marie Vanelle, Anne Sauvaget
BACKGROUND: The treatment of depression remains a challenge since at least 40% of patients do not respond to initial antidepressant therapy and 20% present chronic symptoms (more than 2 years despite standard treatment administered correctly). Repetitive transcranial magnetic stimulation (rTMS) is an effective adjuvant therapy but still not ideal. Intermittent Theta Burst Stimulation (iTBS), which has only been used recently in clinical practice, could have a faster and more intense effect compared to conventional protocols, including 10-Hz high-frequency rTMS (HF-rTMS)...
January 13, 2017: Trials
https://www.readbyqxmd.com/read/28081543/randomised-phase-ii-trial-of-irinotecan-plus-s-1-in-patients-with-gemcitabine-refractory-pancreatic-cancer
#6
T Ioka, Y Komatsu, N Mizuno, A Tsuji, S Ohkawa, M Tanaka, H Iguchi, A Ishiguro, M Kitano, T Satoh, T Yamaguchi, K Takeda, M Kida, K Eguchi, T Ito, M Munakata, T Itoi, J Furuse, C Hamada, Y Sakata
BACKGROUND: We aimed to compare the efficacy and safety of irinotecan/S-1 (IRIS) therapy with S-1 monotherapy in patients with gemcitabine-refractory pancreatic cancer. METHODS: Patients were treated with oral S-1 (80-120 mg for 14 days every 4 weeks) plus intravenous irinotecan (100 mg m(-2) on days 1 and 15 every 4 weeks; IRIS group) or oral S-1 group (80-120 mg daily for 28 days every 6 weeks). The primary endpoint was progression-free survival (PFS)...
January 12, 2017: British Journal of Cancer
https://www.readbyqxmd.com/read/28079501/clinical-efficacy-of-oral-alendronate-in-ankylosing-spondylitis-a-randomised-placebo-controlled-trial
#7
Lucy Coates, Jonathan C Packham, Paul Creamer, Sarah Hailwood, Ashley S Bhalla, Kuntal Chakravarty, Diamuid Mulherin, Gordon Taylor, Derek L Mattey, Ashok K Bhalla
OBJECTIVES: A prospective, double blind, randomised, placebo controlled trial over 2 years was performed to test the efficacy of alendronate, an oral aminobisphosphonate, in improving symptoms and arrest disease progression in patients with mild to severe ankylosing spondylitis (AS). METHODS: 180 patients with AS were randomised to receive weekly alendronate 70 mg or placebo (1:1 randomisation). BAS-G was the primary outcome measure with Bath indices as secondary outcomes...
January 4, 2017: Clinical and Experimental Rheumatology
https://www.readbyqxmd.com/read/28078669/maintenance-phase-in-puva-phototherapy-of-early-stage-mycosis-fungoides-a-critically-appraised-topic
#8
REVIEW
V Grandi, C Delfino, A Pileri, N Pimpinelli
A 65-years-old patient affected by mycosis fungoides stage IB achieved complete remission after a cycle of PUVA phototherapy. As suggested by USCLC guidelines(1) , the patient should be kept in maintenance phase, defined as "period of gradual decrease of frequency of UVL while in clinical remission before discontinuation of phototherapy" by slowly tapering the number of PUVA applications over time up to clinical relapse. USCLC also suggest a standardized schedule for maintenance phase (table 1). Alternatively, the patient could end PUVA therapy and go straight to follow up...
January 12, 2017: British Journal of Dermatology
https://www.readbyqxmd.com/read/28078474/clinical-audit-effectively-bridges-the-evidence-practice-gap-in-chronic-subdural-haematoma-management
#9
Jignesh Tailor, D Fernando, Z Sidhu, R Foley, K D Abeysinghe, D C Walsh
BACKGROUND: Placement of a subdural drain after drainage of chronic subdural haematoma (CSDH) has been shown to reduce the rate of recurrence in several randomised controlled trials (RCT). The most recently published RCT was from Cambridge, UK, in 2009. Despite class I evidence for the use of subdural drains, it is unclear whether these results have been translated into clinical practice. In this clinical audit we review the use of subdural drains in our institution before and after the publication of the 2009 RCT results...
January 11, 2017: Acta Neurochirurgica
https://www.readbyqxmd.com/read/28078350/efficacy-and-safety-of-extended-thromboprophylaxis-for-medically-ill-patients-a-meta-analysis-of-randomised-controlled-trials
#10
Francesco Dentali, Nicola Mumoli, Domenico Prisco, Andrea Fontanella, Matteo Nicola Dario Di Minno
Compelling evidence suggests that the risk of pulmonary embolism (PE) and deep-vein thrombosis (DVT) persists after hospital discharge in acutely-ill medical patients. However, no studies consistently supported the routine use of extended-duration thromboprophylaxis (ET) in this setting. We performed a meta-analysis to assess efficacy and safety of ET in acutely-ill medical patients. Efficacy outcome was defined by the prevention of symptomatic DVT, PE, venous thromboembolism (VTE) and VTE-related mortality...
January 12, 2017: Thrombosis and Haemostasis
https://www.readbyqxmd.com/read/28077962/the-influence-of-duodenally-delivered-shakuyakukanzoto-shao-yao-gan-cao-tang-on-duodenal-peristalsis-during-endoscopic-retrograde-cholangiopancreatography-a-randomised-controlled-trial
#11
Haruka Fujinami, Shinya Kajiura, Jun Nishikawa, Takayuki Ando, Toshiro Sugiyama
BACKGROUND: Anti-cholinergic agents may be used to inhibit duodenal peristalsis, but they may have adverse effects. Shakuyakukanzoto (Shao Yao Gan Cao Tang) has an anti-spasmodic effect and has been used before for oesophagogastroduodenoscopy and colonoscopy. This randomised clinical trial aimed to evaluate the inhibitory effect of Shakuyakukanzoto on duodenal peristalsis, and its usefulness when administered into the duodenum just before endoscopic retrograde cholangiopancreatography (ERCP)...
2017: Chinese Medicine
https://www.readbyqxmd.com/read/28077754/double-blinded-randomised-placebo-controlled-clinical-trial-of-individualised-homeopathic-treatment-of-hyperthyroid-cats
#12
A L Bodey, C J Almond, M A Holmes
Feline hyperthyroidism is a common endocrine disorder in older cats for which homeopathic treatment has been advocated. A double-blinded, placebo-controlled randomised trial was performed to look for evidence of efficacy for the use of individualised homeopathy in the treatment of this disease. Using a case definition of a concentration of the thyroid hormone T4 >66 nmol/l, cats were randomised into two treatment arms. Either a placebo or a homeopathic treatment was given to each cat blindly. After 21 days, the T4 levels, weight (Wt) and heart rate (HR) were compared with pretreatment values...
January 11, 2017: Veterinary Record
https://www.readbyqxmd.com/read/28077366/effectiveness-of-acupuncture-in-women-with-polycystic-ovarian-syndrome-undergoing-in-vitro-fertilisation-or-intracytoplasmic-sperm-injection-a-systematic-review-and-meta-analysis
#13
Junyoung Jo, Yoon Jae Lee
OBJECTIVES: The aim of this systematic review was to assess the evidence from randomised controlled trials (RCTs) on the efficacy, effectiveness and safety of acupuncture in women with polycystic ovarian syndrome (PCOS) undergoing in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI). METHODS: We searched a total of 15 databases through October 2015. The participants were women with PCOS (diagnosed using the Rotterdam criteria) undergoing IVF or ICSI...
January 11, 2017: Acupuncture in Medicine: Journal of the British Medical Acupuncture Society
https://www.readbyqxmd.com/read/28077355/no-evidence-for-the-use-of-stem-cell-therapy-for-tendon-disorders-a-systematic-review
#14
Haiko I M F L Pas, Maarten H Moen, Hidde J Haisma, Marinus Winters
INTRODUCTION: Stem cells have emerged as a new treatment option for tendon disorders. We systematically reviewed the current evidence for stem cell therapy in tendon disorders. METHODS: Randomised and non-randomised controlled trials, cohort studies and case series with a minimum of 5 cases were searched in MEDLINE, CENTRAL, EMBASE, CINAHL, PEDro and SPORTDiscus. In addition, we searched grey literature databases and trial registers. Only human studies were included and no time or language restrictions were applied to our search...
January 11, 2017: British Journal of Sports Medicine
https://www.readbyqxmd.com/read/28077151/multi-strategic-intervention-to-enhance-implementation-of-healthy-canteen-policy-a-randomised-controlled-trial
#15
Luke Wolfenden, Nicole Nathan, Lisa M Janssen, John Wiggers, Kathryn Reilly, Tessa Delaney, Christopher M Williams, Colin Bell, Rebecca Wyse, Rachel Sutherland, Libby Campbell, Christophe Lecathelinais, Chris Oldmeadow, Megan Freund, Sze Lin Yoong
BACKGROUND: Internationally, governments have implemented school-based nutrition policies to restrict the availability of unhealthy foods from sale. The aim of the trial was to assess the effectiveness of a multi-strategic intervention to increase implementation of a state-wide healthy canteen policy. The impact of the intervention on the energy, total fat, and sodium of children's canteen purchases and on schools' canteen revenue was also assessed. METHODS: Australian primary schools with a canteen were randomised to receive a 12-14-month, multi-strategic intervention or to a no intervention control group...
January 11, 2017: Implementation Science: IS
https://www.readbyqxmd.com/read/28077104/effects-of-treadmill-exercise-versus-flutter%C3%A2-on-respiratory-flow-and-sputum-properties-in-adults-with-cystic-fibrosis-a-randomised-controlled-cross-over-trial
#16
Tiffany J Dwyer, Rahizan Zainuldin, Evangelia Daviskas, Peter T P Bye, Jennifer A Alison
BACKGROUND: Treadmill exercise and airway clearance with the Flutter® device have previously been shown to improve mucus clearance mechanisms in people with cystic fibrosis (CF) but have not been compared. It is therefore not known if treadmill exercise is an adequate form of airway clearance that could replace established airway clearance techniques, such as the Flutter®. The aim of this study was to evaluate respiratory flow, sputum properties and subjective responses of treadmill exercise and Flutter® therapy, compared to resting breathing (control)...
January 11, 2017: BMC Pulmonary Medicine
https://www.readbyqxmd.com/read/28076735/reducing-medication-errors-in-hospital-discharge-summaries-a-randomised-controlled-trial
#17
Erica Y Tong, Cristina P Roman, Biswadev Mitra, Gary S Yip, Harry Gibbs, Harvey H Newnham, De Villiers Smit, Kirsten Galbraith, Michael J Dooley
OBJECTIVES: To evaluate whether pharmacists completing the medication management plan in the medical discharge summary reduced the rate of medication errors in these summaries. DESIGN: Unblinded, cluster randomised, controlled investigation of medication management plans for patients discharged after an inpatient stay in a general medical unit. SETTING: The Alfred Hospital, an adult major referral hospital in metropolitan Melbourne, with an annual emergency department attendance of about 60000 patients...
January 16, 2017: Medical Journal of Australia
https://www.readbyqxmd.com/read/28076656/combined-inhaled-beta-agonist-and-anticholinergic-agents-for-emergency-management-in-adults-with-asthma
#18
REVIEW
Scott W Kirkland, Christine Vandenberghe, Britt Voaklander, Taylor Nikel, Sandra Campbell, Brian H Rowe
BACKGROUND: Inhaled short-acting anticholinergics (SAAC) and short-acting beta₂-agonists (SABA) are effective therapies for adult patients with acute asthma who present to the emergency department (ED). It is unclear, however, whether the combination of SAAC and SABA treatment is more effective in reducing hospitalisations compared to treatment with SABA alone. OBJECTIVES: To conduct an up-to-date systematic search and meta-analysis on the effectiveness of combined inhaled therapy (SAAC + SABA agents) vs...
January 11, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28074482/remote-ischaemic-preconditioning-suppresses-endogenous-plasma-nitrite-during-ischaemia-reperfusion-a-randomised-controlled-crossover-pilot-study
#19
Ashok Nair, Sitara Khan, Sami Omar, Xiao-Qing Pei, Karen McNeill, Phil Chowienczyk, Andrew James Webb
AIM: To test the hypothesis that remote ischaemic preconditioning (RIPC) increases circulating endogenous local and systemic plasma [nitrite] during RIPC and ischaemia-reperfusion (IR) as a potential protective mechanism against ischaemia-reperfusion injury (IRI). METHODS: Six healthy male volunteers (mean age 29.5 ± 7.6 years) were randomised in a cross-over study to initially receive either RIPC (4 x 5 min cycles) to the left arm, or no RIPC (Control), both followed by an ischaemia-reperfusion (IR) sequence (20 min cuff inflation to 200 mmHg, 20 min reperfusion) to the right arm...
January 10, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28073811/exploratory-trials-in-mental-health-anything-to-learn-from-other-disciplines
#20
Sven Trelle
OBJECTIVE: Confirmatory randomised controlled trials require solid justifications, especially with regard to whether the experimental intervention is promising. Such evidence is generated in exploratory trials. However, empirical evidence shows that the quality of such trials is still suboptimal. More generally, the development process of healthcare interventions and especially of drugs, remains inefficient. Over the past 10-20 years, a vast amount of methodological work has been published about exploratory trials...
January 10, 2017: Evidence-based Mental Health
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